A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-08-31

Brief Summary

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The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori.

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Detailed Description

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All patients included in this randomized controlled clinical trial will be selected according to strict inclusion and exclusion criteria. At the same time, the benefits and risks of participating in this trial will be explained to the patients before the start of the study, the patients' right to informed consent will be respected, and the informed consent will be signed. After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participants and investigator) in a 1:1:1:1 ratio to Lactobacillus plantarum (1.5×10\^10 per time, three times daily) or Bacillus coagulans (1.5×10\^10 per time, three times daily) or Lactobacillus plantarum + Bacillus coagulans (1.5×10\^10 per time, three times daily) or placebo ( 15g per time, three times daily). At the same time, volunteers will be recruited from healthy people to perform the same treatment.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The person in charge of assigning patients to treatment groups does not know which treatments the patients receive, so they do not select patients in order of their own volition.

Patients themselves do not know what treatment they are receiving, so they do not change their compliance or reporting of symptoms.

Study Groups

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Lactobacillus plantarum

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Group Type EXPERIMENTAL

Lactobacillus plantarum

Intervention Type OTHER

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Bacillus coagulans

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Group Type EXPERIMENTAL

Bacillus coagulans

Intervention Type OTHER

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Lactobacillus plantarum + Bacillus coagulans

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Group Type EXPERIMENTAL

Lactobacillus plantarum + Bacillus coagulans

Intervention Type OTHER

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Placebo

Adult milk powder 15 g per time, three times daily and half an hour before meal.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Adult milk powder 15 g pertime, three times daily and half an hour before meal.

Interventions

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Lactobacillus plantarum

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Intervention Type OTHER

Bacillus coagulans

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Intervention Type OTHER

Lactobacillus plantarum + Bacillus coagulans

1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.

Intervention Type OTHER

Placebo

Adult milk powder 15 g pertime, three times daily and half an hour before meal.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 18-75 years.
* Diagnosed by 13C-UBT within 2 weeks before entry.

Exclusion Criteria

* Previous treatment for H. pylori infection.
* Administration of antibiotics, probiotics/prebiotics, PPIs, H2 receptor antagonists, bismuth preparations, laxatives, anti-diarrhoeals, and certain antimicrobial traditional Chinese medicines 4 weeks before.
* Previous history of gastrointestinal surgery.
* Severe or unstable diseases.
* Pregnancy or lactation.
* Alcoholics and drug abusers.
* Staff of this trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes